DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The amendment filed 04/18/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application of the European patent application EP 20315355 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 07/21/2021 see MPEP 1893.03(b). Therefore, the specification amendment of 07/23/2020 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 30, 32-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gabriel et al (US 20190091412 A1).
Regarding claim 30, Gabriel discloses an electronic system (102, figs 5-6B) for a drug delivery device100, the electronic system comprising:
at least one user interface member (button 122) arranged to be manipulated by a user of the drug delivery device, wherein the user interface member has an exterior operation surface 121 [0078-0079,0080-0081] arranged and configured to be touched by the user of the drug delivery device during operation of the drug delivery device; and
an electrical user proximity detection unit (“proximity sensor”) configured to generate a signal via processor 128 when the user is close to or touches the exterior operation surface [0074, 0078, 0079];
the exterior operation surface 121 comprises a setting surface at 120 of the user interface member 122 which is arranged to be contacted for conducting or initiating a dose setting operation, and wherein the exterior operation surface is the setting surface [0078, 0080].
Regarding claim 32, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises an electrical sensor that is arranged and configured to detect whether the user is close to the exterior operation surface or touches the exterior operation surface, and wherein the sensor is a contactless or touchless proximity sensor, and/or wherein the user proximity detection unit comprises an electrical sensor that is arranged and configured to detect whether the user touches the exterior operation surface, and wherein the sensor is a contact sensor [0078-0079].
Regarding claim 33, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises a capacitive sensor that is arranged and configured to detect whether the user is close to or touches the exterior operation surface [0078].
Regarding claim 34, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises a sensor that comprises at least one electrically conductive contact surface accessible on the exterior operation surface, wherein the sensor is arranged and configured to detect whether the user touches the exterior operation surface 121 [0079-0080].
Regarding claim 35, Gabriel discloses the user proximity detection unit (“proximity sensor”) comprises a sensor that comprises multiple electrically conductive contact surfaces (touch screen, [0080] accessible on the exterior operation surface, wherein at least two electrically conductive contact surfaces of the multiple electrically conductive contact surfaces are arranged such that the user can simultaneously touch the at least two electrically conductive contact surfaces with one finger or two different fingers of a hand of the user, and wherein the at least two electrically conductive contact surfaces are configured to be surfaces having different electrical potentials, wherein the electronic system is configured such that the signal is formed by a current flowing through the hand of the user from one of the electrically conductive contact surfaces to another one of the electrically conductive contact surfaces when the user touches both contact surfaces simultaneously.
Regarding claim 36. Gabriel further discloses comprising an electronic control unit 128 (fig 6A-6B) configured to control an operation of the electronic system in response to the signal of the user proximity detection unit, wherein the electronic system has a first state and a second state, wherein the electronic system has a higher electrical power consumption in the second state as compared to the first state, wherein the electronic system further comprises an electrical use detection unit operatively connected to the electronic control unit, wherein the electrical use detection unit is configured to generate a use signal that indicates the user intends to perform a dose setting operation and/or a dose delivery operation, wherein the electronic system is configured to be switched from the first state into the second state in response to the use signal, wherein the use detection unit comprises the user proximity detection unit, and wherein the use signal is the signal generated by the user proximity detection unit when the user is close to or touches the exterior operation surface [0080- 0083].
Regarding claim 37, Gabriel discloses the electronic system comprises a motion sensing unit, wherein the motion sensing unit is configured to generate electrical motion signals suitable to quantify a relative movement of a first member relative to a second member, wherein the motion sensing unit is configured to be switched by the electronic control unit from a first state, in which the motion sensing unit is not operative, into a second state, in which the motion sensing unit is operative, in response to the use signal, and wherein the electronic system is configured such that the motion sensing unit operates during the dose delivery operation [ 0079-0081, 0100].
Regarding claim 38, Gabriel discloses the exterior operation surface 121 associated with generating the use signal is the setting surface, and the motion sensing unit is configured to monitor the dose delivery operation.
Regarding claim 39, Gabriel discloses the exterior operation surface 121 comprises a delivery surface at 106,122 arranged to be contacted for conducting or initiating a dose delivery operation, and wherein the exterior operation surface associated with generating the use signal is the delivery surface, and the motion sensing unit is configured to monitor the dose delivery operation [ 0079-0081, 0100].
Regarding claim 40, Gabriel discloses a wake-up unit [0079] configured to generate an electrical wake-up signal, wherein the electronic system is configured to switch the user proximity detection unit from a first state to a second state of higher power consumption in response to the wake-up signal, wherein the wake-up unit comprises an electrical wake-up sensor configured to generate the electrical wake-up signal [0079].
Regarding claim 41, Gabriel discloses wherein the electrical wake-up sensor is a vibration sensor [0079-0080].
Regarding claim 42, Gabriel discloses the electronic system is configured as a reusable add-on system for a disposable drug delivery device unit [0004, can be reusable or not].
Regarding claims 43-45, Gabriel discloses further comprising at least one sensor configured to be deactivated in response to the signal generated by the user proximity detection unit and the at least one sensor which is deactivated is the same sensor generating the signal of the user proximity detection unit in response to which it is deactivated; further comprising at least one sensor configured to have a response rate that changes in response to the signal generated by the user proximity detection unit, wherein the response rate of the at least one sensor or switch is increased or decreased in response to the signal generated by the user proximity detection unit ([0079-0080], wake-up of the touch screen implies a change in response rate i) a change of response rate (even if it is from non-respondent to respondent) and also ii) the presence of a deactivation sequence).
Regarding claim 46, Gabriel discloses further comprising at least one sensor configured to be deactivated or to change its response rate in response to the signal generated by the user proximity detection unit, and wherein the at least one sensor is different from a sensor that generates the signal of the proximity detection unit ([0079-0080], wake-up of the touch screen implies a change in response rate i) a change of response rate (even if it is from non-respondent to respondent) and also ii) the presence of a deactivation sequence).
Regarding claim 47, Gabriel discloses further comprising at least one sensor configured to change its response rate in response to the signal generated by the user proximity detection unit, wherein the user proximity detection unit comprises the at least one sensor, wherein the at least one sensor is the same as a sensor that generates the signal of the user proximity detection unit ([0079-0080], wake-up of the touch screen implies a change in response rate i) a change of response rate (even if it is from non-respondent to respondent) and also ii) the presence of a deactivation sequence).
Regarding claim 48, Gabriel discloses a drug delivery device 100 comprising:
an electronic system 102 that comprises at least one user interface member (button 122) arranged to be manipulated by a user of the drug delivery device, wherein the user interface member has an exterior operation surface 121 [0078-0079,0080-0081] arranged and configured to be touched by the user of the drug delivery device during operation of the drug delivery device; and
an electrical user proximity detection unit (proximity sensor) configured to generate a signal when the user is close to or touches the exterior operation surface [0078,0079], wherein the drug delivery device comprises a reservoir with drug [0079], wherein the exterior operation surface 121 is a setting surface at 120 of the user interface member 122 which is arranged to be contacted by the user for conducting or initiating a dose setting operation [0078],
Regarding claim 49, Gabriel discloses the drug delivery device 100 is configured such that the device increases its length during a dose setting operation in an amount proportional to a size of a set dose (figs 11-16).
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
In response to applicant’s arguments that “his application is the U.S. national stage entry of International Application
PCT/EP2021/070314, filed July 21, 2021, published as WO 2022/018106 Al, and claiming priority to EP 20315355.6. The priority application (EP 20315355.6) is properly referenced in the published PCT application, and its subject matter is necessarily considered in evaluating priority under 35 U.S.C. §§ 119 and 365. The substance of the EP priority application has therefore been part of the intrinsic disclosure record since the filing of the PCT application.
Amending the specification to explicitly state incorporation by reference of a properly identified priority document is a common and permissible practice, consistent with MPEP § 608.01(p), which recognizes that incorporation by reference may be used to clarify cross-referenced documents without introducing new matter.”. The examiner partially disagrees.
The examiner acknowledges that applicant is claiming priority to EP 20315355.6 in the PCT/EP2021/070314, but the incorporation by reference statement in the first paragraph of the Specification in the later application US 18/016,995 is improper since it was not previously provided in the first paragraph of the Specification in PCT/EP2021/070314 .
In MPEP §608.01(p) (I)(B) states:
“…As a safeguard against the omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, applicant may include a statement at the time of filing of the later application incorporating by reference the prior application. See MPEP § 201.06(c) and 211 et seq. where domestic benefit is claimed. See MPEP §§ 213 - 216 where foreign priority is claimed. See MPEP § 217 regarding 37 CFR 1.57(b). The inclusion of such an incorporation by reference statement in the later-filed application will permit applicant to include subject matter from the prior application into the later-filed application without the subject matter being considered as new matter. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). Although, as discussed above, an incorporation by reference statement can be used as a safeguard against an omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, it should be noted that an incorporation by reference statement will not satisfy the specific reference requirement of 35 U.S.C. 119(e) or 120 or 37 CFR 1.78. See Droplets, Inc. v. E*TRADE Bank, 887 F.3d 1309, 126 USPQ2d 317 (Fed. Cir. 2018).”.
Also, in MPEP 1893.03(b) states:
“An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that
An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.”.
Similarly, PCT Article 11(3) provides that
...an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.”....
Applicant failed to include “incorporation by reference” on the first line of the Specification of the International application PCT/EP2021/070314 at the time of the filing. In other words, the incorporation by reference was made after the filing date and that the international application didn't include an incorporation by reference to the foreign priority. Claiming priority is not the same as incorporation by reference. Therefore, the addition of the incorporation by reference after the filing date constitutes new matter.
The examiner recommends to remove the “incorporation by reference” in US application 18/016,995 specification.
With respect to applicant’s arguments about “there is no teaching in Gabriel that the setting surface includes a touch-sensitive region that generates the claimed use signal.”. The examiner would like to point out that the whole disclosure in Gabriel should be considered and not just the sections the examiner points out in the rejection. In [0078] (also further included in the rejection above), Gabriel set forth that the setting surface includes a touch-sensitive surface to be contacted by the user for conducting or initiating a dose setting operation [via processor 128 [0081]. The processor must receive a signal in order to activate the injection [0006,0010,0056, 0074, 0080,0081, etc.].
In response to arguments that “a person of ordinary skill in the art would readily understand that the dose setting surface of Gabriel is not the touch-sensitive surface 121 of the button 122, but rather the circumferential surface of the control wheel 106, comprising the illustrated grooves/protrusions, via which the rotary knob 120 can be rotated. Any other interpretation would contradict the "rotary" characteristic of the knob 120. Thus, Gabriel does not disclose an exterior operation surface as the setting surface that arranged to be contacted by the user for conducting or initiating a dose setting operation and an electrical user proximity detection unit configured to generate a signal when the user is close to or touches the exterior operation surface, as recited in amended claims 30 and 48”, the examiner disagree.
The examiner included paragraphs in the rejection above pointing out the claimed features to further clarify where is further supported by Gabriel. It is noted there is not enough structural language in the claims to overcome Gabriel. Therefore, Gabriel meets the limitations set forth in Claims 30 and 40 as claimed.
The examiner recommends to further amend the claims to differentiate applicant’s invention from Gabriel.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783